GlycoNex has dosed the first patient in a multinational Phase I trial of GNX1021, moving its lead glycan-directed antibody-drug conjugate from laboratory studies into human testing. The milestone begins a far more consequential phase in which investigators must establish whether targeting branched Lewis B/Y can produce a usable therapeutic window in advanced gastrointestinal cancers.
BIOTRONIK Neuro adds AI-guided outreach to Prospera SCS, but broader validation will determine its impact on chronic pain support.
Moleculin Biotech has reported a preliminary 37% composite complete remission rate among 62 evaluable patients in Part A of its pivotal Phase 2/3 MIRACLE trial of Annamycin plus cytarabine for relapsed or refractory acute myeloid leukemia. The July 31 update also showed a 24% complete remission rate across the blinded study population. Among 30 evaluable
Pfizer’s Phase 3 LITFULO vitiligo results strengthen its filing case, but dose, safety and durability details remain decisive.
SoundHealth’s latest Series A takes total funding to $12.25 million as Sonu and Spatial Sleep enter a tougher commercial scale-up phase.
Verdiva Bio has begun Phase 1 testing of weekly oral amylin candidate VRB-103. See what the trial can prove and what remains uncertain.
The United States Food and Drug Administration (FDA) has classified Resmed Ltd.’s correction of certain Astral 100 and Astral 150 ventilators as a Class I recall after a leaking internal component was linked to five serious injuries and the potential for ventilation therapy to stop without warning. The action covers 168,069 devices distributed worldwide and
The United States Food and Drug Administration (FDA) has approved MannKind Corporation’s Furoscix ReadyFlow, a prefilled autoinjector that delivers 80 milligrams of subcutaneous furosemide in about ten seconds for adults experiencing edema associated with chronic heart failure or chronic kidney disease. The July 24 approval creates a faster alternative to the existing Furoscix On-body Infusor,
Evommune begins a Phase 2b EVO756 migraine trial after a urticaria setback, testing whether MRGPRX2 inhibition can deliver preventive benefit.
Eli Lilly and Resilience are investing $750 million to expand U.S. KwikPen production in Ohio. See why manufacturing execution now matters.